14775 – Quality Technician – Carlow Contractor

Purpose:

This is an 11-month contract position. Work a 4 shift pattern role.

Responsibilities:

• Technical knowledge of sterile manufacturing processes.

• Perform timely reviews of batch documentation/investigations/reports highlighting and assisting in the resolution of concerns commensurate with the risk.

• Respond quickly to unplanned events and technical issues.

• Operational experience with quality systems in a dynamic manufacturing environment eg SAP, Trackwise, MES.

• Full understanding of relevant quality and compliance regulations knowledge of requirements for cGMP, US, and EU regulatory requirements.

• Conduct, report, and display of Quality right the first time, audit readiness metrics weekly to ensure continuous audit readiness and cGMP compliance.

• Support the spot check/walk-through process of the production lines.

• Involved in customer complaint investigation if required.

• Support the annual product quality reviews if required.

• Provide Quality support to IPT production teams to ensure cGMP standards are maintained.

• Understanding sterile manufacturing operations is preferred.

• Ability to learn and utilize computerized systems for the daily performance of tasks.

• Ability to prioritize, manage multiple tasks, and meet deadlines.

• Perform timely reviews on batch documentation ( EBR’s ) / line clearances/ assist in the resolution of concerns commensurate with the other Department representatives to promote improvements in GMP and Quality standards.

• Keep abreast of the latest developments from regulatory authorities in relation to Quality Compliance activities.

• Comply with our current Manufacturing Division, Quality and EHS Management System requirements, as relevant to commercial operations.

• Foster a culture of continuous improvement by deploying company Six Sigma tools and supporting the implementation of Model Area within operations from the start.

Minimum Qualifications and Experience: 

• Degree qualification or equivalent (Science, Engineering, Technical.)

• Experience in Sterile Manufacturing.

• Sterile filling processes and equipment and support services experience.

• Lean Six Sigma Methodology experience desired.

• Good organizational skills and attention to detail.

• Requires good written, verbal, and interpersonal communication skills and the ability to effectively interact cross-functionally.

• Ability to learn and utilize computerized systems for the daily performance of tasks.

• Strong influencing skills.

• Demonstrable analytical and systematic problem-solving skills.